Please Wait a Moment
X

Articles

04Jan

FDA Updates Emergency Use Authorization for COVID-19 Convalescent Plasma

04 Jan, 2022 | Return|

On December 28, 2021, the FDA updated the emergency use authorization  (EUA) for COVID-19 convalescent plasma.  The update limits the authorization to the use of COVID-19 convalescent plasma with high titers of anti -SARS-CoV-2 antibodies for the treatment of COVID-19 in patients with immunosuppressive disease or who are receiving immunosuppressive treatment.  Additionally, to help assure the manufacture of high titer COVID-19 convalescent plasma, the revisions to the EUA define acceptable tests and increase qualifying result cutoffs to be used for manufacturing COVID-19 convalescent plasma with high titers of anti-SARS-CoV-2 antibodies.

We are currently evaluating our options to determine if we can provide additional testing services using one of the newly defined assays. Please reach out to your customer service manager if your organization is considering CCP testing under the updated guidelines. 

 

 

 

Related

Assay History List

We have now added a new section called the "Assay History List" to the "At A Gla...

Read More >

Happy New Year!

We are very excited to launch our new website! Please take a few moments to click around and explore...

Read More >

FDA announces withdrawal of Guidance for ZIKV Testing

We are informing you that the FDA has announced their withdrawal of Guidance for ZIKV Testing. In th...

Read More >

Confirmatory Testing Delay for HIV-1 Western Blot and HIV-2 EIA

Currently, there are limited supplies of the reagents used for HIV-1 Western Blot and HIV-2 EIA test...

Read More >

Reminder- Check flights and cargo hours for the 4th of July Holiday

As a friendly reminder, airlines often change their routine flights and cargo hours for holidays. We...

Read More >

CTS implements Ultrio Plus on the Panther

In 2016, the Procleix Panther instrument was introduced by Grifols in support of automated NAT ZIKA ...

Read More >